FDA-Inspected Site

Depuy International Ltd.

6 FDA inspections are on record for Depuy International Ltd. in Leeds, United Kingdom.

483· Form 483 issued

Leeds, United Kingdom · Last updated August 15, 2026

Overview

  • 6 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-29.

At a glance

Inspections

6

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
26 May 2026 – 29 May 2026Medical Devices & Rad Health483View 483 →
22 May 2017 – 26 May 2017Medical Devices & Rad HealthClean
22 Jun 2015 – 25 Jun 2015Medical Devices & Rad Health483View 483 →
16 Feb 2012Not recorded483View 483 →
15 Aug 2002Not recordedClean
23 Mar 2000Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

29 May 2026
ISO 13485:2016 Clause 7.5.1

Production controls not adequate

Cited by Albert L Nguyen

25 Jun 2015
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Stephen D Eich

25 Jun 2015
21 CFR 820.30(g)

Design validation - user needs and intended uses

Cited by Stephen D Eich

16 Feb 2012
21 CFR 803.52(f)(1)

Type of Reportable Event

Cited by Michael J Nerz

16 Feb 2012
21 CFR 820.20(a)

Management ensuring quality policy is understood

Cited by Michael J Nerz

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 803.52(f)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.20(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.1Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Depuy International Ltd.'s 3 Form 483s

Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat